Study of GRT-R910 COVID-19 Boost Vaccine in Healthy Volunteers

COVID-19 Clinical Trial

Official title:

A Phase 1 Trial to Evaluate the Safety, Immunogenicity, and Reactogenicity of a Self-Amplifying mRNA Prophylactic Vaccine Boost Against SARS-CoV-2 in Previously Vaccinated Healthy Adults 18 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148962
• Other study ID #: GO-009
• Status: Completed
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: May 26, 2023

Study information

• Verified date: July 2023
• Source: Gritstone bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the safety and tolerability of 2 different doses (10 or 30 mcg) of GRT-R910 when administered as a boost in healthy adults previously vaccinated with the AstraZeneca, Janssen/Johnson and Johnson, Moderna, or Pfizer/BioNTech COVID-19 vaccines.

Description:

This trial will study a self-amplifying mRNA (samRNA) based vaccine (GRT-R910) in previously vaccinated adults (≥18 years). GRT-R910 uses a codon optimized, prefusion stabilized Spike (S) cassette with additional T cell epitopes (TCEs) covering multiple epitopes from non-spike proteins to safely drive strong, broad, and durable B and T cell immune responses to SARS-CoV-2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For Cohorts 1 and 2, have received AstraZeneca's COVID-19 prime and boost vaccine at least 2 months prior to study participation.

• For Cohort 3, have previously received Janssen/Johnson and Johnson or AstraZeneca vaccine with or without booster dose(s) of an authorized vaccine at least 2 months prior to Day 1.

• For Cohorts 4 and 6, have previously received an mRNA COVID-19 vaccine with or without booster dose(s) of an authorized vaccine with the last dose received at least 2 months prior to Day 1.

• Agree to refrain from blood donation during the course of the study.

• Women of childbearing potential (WOCBP)* must agree to avoid pregnancy and be willing to use a highly effective method of contraception** consistently for 30 days prior to the first study vaccine and for at least 60 days after the last study vaccine

• Male participants of childbearing potential must agree to the use of condoms to ensure effective contraception with a female partner from the time of study vaccination until 3 months after vaccination.

• Plan to remain living in the area for the duration of the study.

Exclusion Criteria:

• History of prior confirmed COVID-19 (cohorts 1 and 2).

• Positive for SARS-CoV-2 by lateral flow test (rapid diagnostic test), enzyme-linked immunosorbent assay (ELISA) or by nasal swab polymerase chain reaction (PCR) at screening (Cohorts 3-6).

• Prior receipt of a SARS-CoV-2 vaccine other than AstraZeneca's AZD1222 (Covishield®, Vaxzevria®), JNJ-78436735, Pfizer/BioNTech (Comirnaty®), Moderna (Spikevax®), other approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with a lipid nanoparticle (LNP) component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data.

• On current treatment or prevention agents with activity against SARS-CoV-2.

• Participation in another research study involving receipt of an investigational product in the 60 days preceding enrollment or planned use during the study period.

• Receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination.

• Receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of first study vaccination or at any time during the study.

• Any confirmed or suspected immunosuppressive or immunodeficient state.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain.

• Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

• Any history of anaphylaxis, including but not limited to reaction to vaccination.

• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).

• History of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation.

• Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.

• Suspected or known current alcohol abuse that in the opinion of the investigator would impede compliance with the protocol and schedules of assessments.

• Suspected or known drug abuse in the 5 years preceding enrollment.

• Any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• GRT-R910 10 mcg Dose (after AZ)
10 mcg vaccine by intramuscular (IM) injection on Day 1 (required) and on Day 113 (optional)
• GRT-R910 30 mcg Dose (after AZ)
30 mcg vaccine by intramuscular (IM) injection on Day 1 (required) and on Day 113 (optional)
• GRT-R910 10 mcg Dose (After Adenovirus based vaccine)
GRT-R910 10 mcg vaccine by intramuscular (IM) injection on Day 1 and on Day 29
• GRT-R910 10 mcg Dose (after mRNA based vaccine)
GRT-R910 10 mcg vaccine by intramuscular (IM) injection on Day 1 and on Day 29

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS	Birmingham
United Kingdom	University Hospital of Leicester NHS Trust	Leicester
United Kingdom	Manchester University	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Gritstone bio, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms		Up to 7 days after each vaccination
Primary	Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms		Up to 7 days after each vaccination
Primary	Number of Participants with One or More Unsolicited Adverse Events (AEs)		Up to 28 days after each vaccination
Primary	Change from Baseline for Clinical Safety Laboratory Parameters		Up to 7 days after each vaccination
Primary	Number of Participants with One or More Serious Adverse Events		Up to ~16 months after each vaccination
Primary	Number of Participants with One or More Adverse Events of Special Interest (AESIs) Including Potentially Immune-Mediated Medical Condition (PIMMCs), Medically Attended Adverse Events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs)		Up to ~16 months after each vaccination
Secondary	Response Rate and magnitude of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples [Time Frame: Up to ~16 months after the prime vaccinationSerum Samples		Up to ~16 months after prime vaccination
Secondary	Response Rate, magnitude, and breath of SARS-CoV-2 Specific T-Cells by Interferon-gamma (IFN-?) Enzyme-Linked Immunospot (IFN-? ELISpot) Assay		Up to ~16 months after prime vaccination